Title: Quality Validation Engineer / Validation Specialist
Location: Swiftwater, PA
Duration: 12 Months+ Possible Extension
Schedule: Monday - Friday; 9 AM - 5 PM
Pay Range: $80-$90/hr
Experience: 6-9 Years
Description:
We are seeking a highly skilled and experienced quality and validation professional to join a dynamic team within a fast-paced, regulated life sciences manufacturing environment.
This role is central to ensuring that all manufacturing processes, equipment, facilities, and systems meet the highest standards of quality, compliance, and regulatory integrity.
The ideal candidate brings deep expertise in quality systems, validation methodologies, and regulatory frameworks, and thrives in a collaborative, cross-functional setting where precision, accountability, and continuous improvement are paramount.
Qualifications & Experience:
Bachelor's degree in Engineering, Life Sciences, or a related technical discipline required; Master's degree preferred.
6-9 years of experience in the pharmaceutical, biopharmaceutical, or other highly regulated manufacturing environments.
Strong background in quality validation, quality systems, and regulatory compliance within the life sciences industry.
Demonstrated experience leading and managing Corrective and Preventive Action (CAPA) investigations and activities.
Comprehensive knowledge of Quality System Regulations (QSR), GxP requirements, and industry best practices.
Experience supporting validation activities, including equipment, process, facility, computerized systems, and documentation review.
Preferred experience in high-speed aseptic filling operations and sterile manufacturing environments.
Proven ability to collaborate effectively with cross-functional teams, including Quality, Manufacturing, Engineering, Validation, and Regulatory Affairs.
Strong analytical and problem-solving skills with exceptional attention to detail.
Ability to manage multiple projects simultaneously while meeting aggressive timelines and strict deadlines.
Excellent verbal and written communication skills, with the ability to present complex information clearly to diverse stakeholders.
Self-motivated, organized, and capable of working independently in a fast-paced, regulated environment.
Key Competencies:
Quality Validation & Compliance
CAPA Management
Regulatory Knowledge (FDA, GMP, GxP, QSR)
Risk Assessment & Root Cause Analysis
Cross-Functional Collaboration
Project Management
Technical Documentation & Reporting
Continuous Improvement & Quality Excellence
Numbers & Facts
Location
Swiftwater, PA
Salary
$80–$90 Per Hour
Skills
Analysis Skillsunmatched
Asepsisunmatched
Best Practicesunmatched
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Communication Skillsunmatched
Continuous Improvementunmatched
Corrective Actionunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Cross-Functionalunmatched
Detail Orientedunmatched
Documentation Reviewunmatched
Environmental Sciencesunmatched
FDA Requirementsunmatched
GMP (Good Manufacturing Practices)unmatched
GxPunmatched
Leadershipunmatched
Manufacturingunmatched
Manufacturing/Industrial Processesunmatched
Multitaskingunmatched
Organizational Skillsunmatched
Presentation/Verbal Skillsunmatched
Problem Solving Skillsunmatched
Project/Program Managementunmatched
Quality Engineeringunmatched
Quality Managementunmatched
Quality System Requirements (QSR)unmatched
Regulationsunmatched
Regulatory Complianceunmatched
Risk Analysisunmatched
Root Cause Analysisunmatched
System Validationunmatched
Team Playerunmatched
Technical Writingunmatched
Time Managementunmatched
Writing Skillsunmatched
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